1. Healthy adults, between 18 and 55 years of age, inclusive.
Item
1. Healthy adults, between 18 and 55 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
2. Body weight >50 kg (110 lbs) and Body Mass Index (BMI) between 19 and 30 kg/m2.
Item
2. Body weight >50 kg (110 lbs) and Body Mass Index (BMI) between 19 and 30 kg/m2.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
3. A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating, is of non-childbearing potential or child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with recognized non-hormonal or hormonal contraceptive methods
Item
3. A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating and if she is of: • non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or post-menopausal females defined as being amenorrheic for greater than 1 year and having follicle stimulating hormone (FSH) levels consistent with menopause. • child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with recognized non-hormonal or hormonal contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug. Recognized non-hormonal contraceptive methods include: abstinence, condoms, diaphragm with spermicide, and intrauterine device (IUD)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0279752 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0278321 (UMLS CUI [6])
C0232970 (UMLS CUI [7,1])
C0002453 (UMLS CUI [7,2])
C0733758 (UMLS CUI [7,3])
C0427780 (UMLS CUI [8])
C0700589 (UMLS CUI [9])
C3843422 (UMLS CUI [10])
C0677582 (UMLS CUI [11])
C0042241 (UMLS CUI [12,1])
C0037862 (UMLS CUI [12,2])
C0021900 (UMLS CUI [13])
4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Item
4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
1. Urine pregnancy test; Positive | Pregnancy | Breast Feeding | Childbearing Potential | Contraceptive methods; Unable; Unwilling
Item
1. For female subjects, a positive urine β-hCG (human chorionic gonadotropin) test at screening indicating pregnancy; nursing women; and women of childbearing potential who are unwilling or unable to use an appropriate form of contraception prior to study medication administration and until completion of follow-up procedures.
boolean
C0430056 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4])
C0700589 (UMLS CUI [5,1])
C1299582 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
Hematological Disease | Endocrine System Diseases | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Bronchopulmonary disease | Condition; Interferes with; drug absorption; drug distribution (pharmacokinetics); drug metabolism; drug elimination | Gastrointestinal Surgical Procedure | Appendectomy | Bleeding tendency; Abnormal | Thrombophlebitis | Physical Examination; Abnormal result | 12 lead ECG; Abnormality | Laboratory; Abnormality
Item
2. Within the judgement of the Principal Investigator and the Sponsor, any clinically significant hematologic, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; any previous gastrointestinal surgery, except appendectomy, if performed more than 3 months prior to study screening; history of abnormal bleeding tendencies or thrombophlebitis; or any clinically relevant abnormality identified on physical examination, 12-lead ECG or clinical laboratories at screening.
boolean
C0018939 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C1096000 (UMLS CUI [7])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0678745 (UMLS CUI [8,3])
C0699903 (UMLS CUI [8,4])
C0683140 (UMLS CUI [8,5])
C0683141 (UMLS CUI [8,6])
C0524722 (UMLS CUI [9])
C0003611 (UMLS CUI [10])
C1458140 (UMLS CUI [11,1])
C0205161 (UMLS CUI [11,2])
C0040046 (UMLS CUI [12])
C0031809 (UMLS CUI [13,1])
C0459424 (UMLS CUI [13,2])
C0430456 (UMLS CUI [14,1])
C1704258 (UMLS CUI [14,2])
C0022877 (UMLS CUI [15,1])
C1704258 (UMLS CUI [15,2])
3. Current or past history of significant renal disease including, but not limited to, any renal insufficiency, nephrolithiasis, microalbuminuria, glomerulonephropathy, glomerulonephritis, or interstitial nephritis.
Item
3. Current or past history of significant renal disease including, but not limited to, any renal insufficiency, nephrolithiasis, microalbuminuria, glomerulonephropathy, glomerulonephritis, or interstitial nephritis.
boolean
C0022658 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0392525 (UMLS CUI [3])
C0730345 (UMLS CUI [4])
C0268731 (UMLS CUI [5])
C0017658 (UMLS CUI [6])
C0027707 (UMLS CUI [7])
4. Cardiovascular Diseases | Angina Pectoris | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Other conduction disorders | Incomplete right bundle branch block | Right bundle branch block | Incomplete left bundle branch block | Left Bundle-Branch Block | Atrioventricular Block | Wolff-Parkinson-White Syndrome | Congestive heart failure | Cardiomyopathies
Item
4. History of clinically significant cardiovascular disease including, but not limited to, angina, coronary artery bypass surgery or percutanenous transluminal coronary angioplasty (PTCA), conduction abnormality [including but not specific to left or right incomplete or complete bundle branch block, atrioventricular (AV) block (any degree), Wolf-Parkinson-White (WPW) syndrome, etc.], congestive heart failure, or cardiomyopathy.
boolean
C0007222 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0340494 (UMLS CUI [5])
C0262525 (UMLS CUI [6])
C0085615 (UMLS CUI [7])
C0281878 (UMLS CUI [8])
C0023211 (UMLS CUI [9])
C0004245 (UMLS CUI [10])
C0043202 (UMLS CUI [11])
C0018802 (UMLS CUI [12])
C0878544 (UMLS CUI [13])
ECG abnormality | EKG: T wave abnormal | ecg non-sinus rhythm | QRS Axis (observable entity); Left axis deviation | QRS Axis (observable entity); Right axis deviation | History of myocardial infarction; Q wave | History of myocardial infarction; ECG Nonspecific ST-T change | Angina Pectoris | Other conduction disorders | Incomplete right bundle branch block | Incomplete left bundle branch block | Right bundle branch block | Left Bundle-Branch Block | Complete atrioventricular block | Wolff-Parkinson-White Syndrome | Sinus Arrest, Cardiac | Paired ventricular premature complexes | Ventricular triplet | ARRHYTHMIA SYMPTOMATIC | Cardiac Arrhythmia; C0231221 Asymptomatic | heart rate | Electrocardiogram: P-R interval | QRS complex duration (observable entity) | QT interval - finding | qtc interval
Item
5. Clinically relevant abnormality on screening ECG, including • Ill-defined T wave • Non-sinus rhythm • Abnormal QRS axis deviation • Evidence of previous myocardial infarction (Q waves, S-T segment changes) • History/evidence of angina • Any conduction abnormality (including but not specific to left or right incomplete or complete bundle branch block, AV block (any degree), WPW syndrome) • Sinus Pauses > 2.5 seconds • Ventricular couplets, triplets or other noted arrhythmia, symptomatic or asymptomatic Heart rate: Males < 40 and > 100 bpm Females < 40 and > 100 bpm PR Interval: Males < 120 and > 200 msec Females < 120 and > 200 msec QRS duration: Males < 70 and >120 msec Females < 70 and > 120 msec QT interval: Males < 340 and > 450 msec Females < 340 and > 470 msec QTc interval (any correction factor): Males < 350 and > 450 msec Females < 350 and > 450 msec
boolean
C1832603 (UMLS CUI [1])
C0438167 (UMLS CUI [2])
C3649284 (UMLS CUI [3])
C0429012 (UMLS CUI [4,1])
C0232297 (UMLS CUI [4,2])
C0429012 (UMLS CUI [5,1])
C0232296 (UMLS CUI [5,2])
C1275835 (UMLS CUI [6,1])
C1305738 (UMLS CUI [6,2])
C1275835 (UMLS CUI [7,1])
C1112720 (UMLS CUI [7,2])
C0002962 (UMLS CUI [8])
C0340494 (UMLS CUI [9])
C0262525 (UMLS CUI [10])
C0281878 (UMLS CUI [11])
C0085615 (UMLS CUI [12])
C0023211 (UMLS CUI [13])
C0151517 (UMLS CUI [14])
C0043202 (UMLS CUI [15])
C1955864 (UMLS CUI [16])
C0429001 (UMLS CUI [17])
C4087466 (UMLS CUI [18])
C0741212 (UMLS CUI [19])
C0003811 (UMLS CUI [20,1])
C0231221 (UMLS CUI [20,2])
C0018810 (UMLS CUI [21])
C0429087 (UMLS CUI [22])
C0429025 (UMLS CUI [23])
C1287082 (UMLS CUI [24])
C0489625 (UMLS CUI [25])
6. Hemoglobin < 11 g/dL at screening; history of hemoglobinopathy; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
Item
6. Hemoglobin < 11 g/dL at screening; history of hemoglobinopathy; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
boolean
C0019046 (UMLS CUI [1])
C0019045 (UMLS CUI [2])
C0025637 (UMLS CUI [3])
C0025635 (UMLS CUI [4,1])
C2826705 (UMLS CUI [4,2])
C0220908 (UMLS CUI [5])
7. Documented or suspected history of allergy to study drug or its components or other allergy, which, in the opinion of the Principal Investigator, contradicts their participation.
Item
7. Documented or suspected history of allergy to study drug or its components or other allergy, which, in the opinion of the Principal Investigator, contradicts their participation.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
8. History of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
Item
8. History of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
boolean
C0020517 (UMLS CUI [1,1])
C0536495 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1882518 (UMLS CUI [2,2])
9. History of sensitivity to heparin or heparin-induced thrombocytopenia.
Item
9. History of sensitivity to heparin or heparin-induced thrombocytopenia.
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
10. Use of prescription or non-prescription drugs (other than acetaminophen in doses < 2 grams/day and multivitamins), within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Item
10. Use of prescription or non-prescription drugs (other than acetaminophen in doses < 2 grams/day and multivitamins), within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
boolean
C0013231 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0000970 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0178602 (UMLS CUI [4])
C0301532 (UMLS CUI [5])
C3173309 (UMLS CUI [6])
11. Dietary Supplements | Herbal Supplements | ST. JOHN'S WORT EXTRACT | Kava preparation | Ephedra | Ginkgo biloba | Dehydroepiandrosterone Sulfate | Yohimbe | Saw palmetto extract | Ginseng Preparation | red yeast rice | Vitamins; Dosage | Session; Before | Discharge; Before | Grapefruit (food) | Date treatment or therapy started
Item
11. Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng, red yeast rice, and excessive doses of vitamins (2-fold greater than the recommended daily allowance) within 14 days or 5 half-lives, whichever is longer, prior to Day -1 of Session 1 and until discharge from the study; or consumption of grapefruit-containing products within 14 days prior to the first dose of study medication.
boolean
C0242295 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C0813171 (UMLS CUI [3])
C0939882 (UMLS CUI [4])
C0950030 (UMLS CUI [5])
C0330206 (UMLS CUI [6])
C0057277 (UMLS CUI [7])
C1123032 (UMLS CUI [8])
C0771607 (UMLS CUI [9])
C1119918 (UMLS CUI [10])
C0763533 (UMLS CUI [11])
C0042890 (UMLS CUI [12,1])
C0178602 (UMLS CUI [12,2])
C1883017 (UMLS CUI [13,1])
C0332152 (UMLS CUI [13,2])
C0030685 (UMLS CUI [14,1])
C0332152 (UMLS CUI [14,2])
C0995150 (UMLS CUI [15])
C3173309 (UMLS CUI [16])
12. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Item
12. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
13. History of smoking or use of nicotine containing products for 3 months prior to study participation.
Item
13. History of smoking or use of nicotine containing products for 3 months prior to study participation.
boolean
C1519384 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
14. History of illicit drug abuse within 6 months of the study.
Item
14. History of illicit drug abuse within 6 months of the study.
boolean
C0743253 (UMLS CUI [1])
15. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Item
15. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1])
C0560579 (UMLS CUI [2])
C0043188 (UMLS CUI [3])
C0559430 (UMLS CUI [4])
C0559433 (UMLS CUI [5])
C0220908 (UMLS CUI [6])
16. Unwillingness to adhere to the study Lifestyle Guidelines as described in Protocol Section 7.
Item
16. Unwillingness to adhere to the study Lifestyle Guidelines as described in Protocol Section 7.
boolean
C0525058 (UMLS CUI [1])
17. Positive urine drug screen (UDS) at screening and pre-dose at each study session.
Item
17. Positive urine drug screen (UDS) at screening and pre-dose at each study session.
boolean
C0743300 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
18. Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody at screening.
Item
18. Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody at screening.
boolean
C0019683 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
C0201487 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
19. Donation of blood in excess of 500 mL within 56 days prior to dosing.
Item
19. Donation of blood in excess of 500 mL within 56 days prior to dosing.
boolean
C0005794 (UMLS CUI [1])